1. Field of the Invention
This invention relates generally to methods of manufacturing devices, and specifically to methods of manufacturing devices comprised of multiple component products.
2. Description of the Related Art
Many manufacturers produce a comprehensive line of component products which are designed to interconnect and function together. It is often desirable for such manufacturers to sell their components separately because the varying needs of their customers would not be readily satisfied by any single combination of components, and it is frequently not economically feasible to assemble the components in accordance with the individual needs of every customer at the manufacturing site. In addition, in some industries, manufacturers make individual components which are capable of being used in combination with the components of other manufacturers in the industry.
As a consequence, the customer usually is faced with the inconvenient task of obtaining the desired component parts from one or more manufacturers and then combining them in the desired configuration. When a customer has a continuous need for such a combination of components, the burden of ordering the components and putting them together may become very time-consuming and expensive.
The problem is especially evident in the medical device industry. For example, medical practitioners often require a variety of components to create a desired intravenous (IV) set. The components of an IV set may include IV drip bags, medical tubing, needleless injection sites, Y-sites, luer connectors, etc. Many of these components are repeatedly used together in certain configurations for specific applications at a given hospital or other care center, but the components are generally sold separately by separate manufacturers.
Some medical device manufacturers have permitted their customers to order combinations of such components pre-assembled. However, as described below, the expense and delay heretofore associated with pre-assembled combinations has often been prohibitive, especially in view of the increasing cost constraints placed upon medical practitioners and medical device companies by insurance companies and the consuming public. Thus, despite the recurrent use of a certain combination at a facility, many medical practitioners have still been forced to order the components separately and then assemble them on site.
An example of a combination of IV set component parts that might be desired at a given hospital is shown in FIG. 1. In this example, a first end of a section of medical tubing 20 is inserted into a first inlet 22 of a Y-site 24. A female luer 26 and a CLAVE 28 fluid connector (manufactured by ICU Medical, Inc. of San Clemente, Calif.) are attached in series to the opposite end of the medical tubing 20. A PIGGY LOCK connector 30 (also available from ICU Medical, Inc.) is attached to a second inlet 32 of the Y-site 24, and a section of medical tubing 36 is coupled to the outlet port 38 of the Y-site 24. The PIGGY LOCK connector is attached to tubing 37 which is attached to a spike 35. The tubing 36 is connected to a luer lock 39 at its opposite end.
The typical prior art procedure for providing a pre-assembled combination of such an IV set is outlined below. A customer first contacts a manufacturing representative of a company which offers one or more of the components of the desired combination. The manufacturing representative then informs the manufacturer of the request and an employee of the manufacturer must then determine whether the requested combination can be provided in view of applicable governmental regulations.
Assuming the combination is permitted by such regulations, the manufacturing representative then arranges for another employee to put together a sample of the desired combination from the component parts. The sample is then sent to a facility for medical sterilization and packaging, returned from the sterilization facility, and then sent to the customer. In this process, if the manufacturer does not make all of the components of the desired combination, the manufacturer may need to obtain one or more of the components from another manufacturer.
It typically takes about ten days from the time the customer originally requests the sample to the time the customer receives the sample. The customer then evaluates the sample to determine whether it is satisfactory. If the customer approves of the sample, the customer must generally place a minimum bulk order of the combination with the manufacturing representative. In most cases, the customer does not have the option of ordering the desired combination in small quantities.
Bulk orders are usually required because the process of assembling and packaging a specific combination requires reconfiguration of the assembly process and special attention by the manufacturing and distribution personnel, entailing additional expenses which are only compensable by the profits resulting from an order of substantial size.
The assembly process usually takes an extended period of time. After assembly, the products must be sterilized and packaged. The process of sending the products to the sterilization facility, performing the sterilization and packaging, and then sending them back to the manufacturer takes more time. As a consequence of the various delays and inefficiencies, the complete process takes approximately four to six months from the time the customer first contacts the manufacturing representative to the time the customer receives the first bulk order.
Another problem associated with this procedure relates to the end cost of the product. As may be appreciated, the cost of labor is the primary cost associated with producing the product. In this process, a substantial number of man hours are spent in this process preparing the sample product. More man hours, and capital expenditure, are required to produce the minimum order of the product. Because of the substantial man-hours associated with the preparation of the product, the cost of the product is very high. This is especially true when viewed in relation to the number of products produced. This cost is passed on to the consumer, after application of a profit margin by the medical device supplier and hospital. In addition, they often produce several times the amount of the product ordered and keep the remaining product in inventory so that subsequent orders can be filled more quickly.
There is thus a need for an improved method of manufacturing pre-assembled combinations of component parts. It is an object of the invention to provide a method in which the customer is given more information at the beginning of the ordering process and the assembly process and wherein the assembly and transportation are efficiently controlled in a manner which provides the product more quickly and at a significant reduction in cost.